Information Processing System, Information Processing Method, and Non-Transitory Computer Readable Medium

This application is based upon and claims the benefit of priority from Japanese patent application No. 2024-051938, filed on Mar. 27, 2024, the disclosure of which is incorporated herein in its entirety by reference.

The present disclosure relates to an information processing system, an information processing method, and a program.

For example, at a medical institution, a specimen such as blood or a part of a tumor of a cancer is taken from a patient, and based on the taken specimen, a so-called personalized vaccine specialized for that patient is generated through a plurality of institutions and companies. Then, the generated personalized vaccine is administered to the same patient at a medical institution (which is the same as or different from the aforementioned medical institution). In regard to such a vaccine generation flow between a medical institution at which a specimen is detected and a medical institution at which a personalized vaccine is administered, a system for managing a product(s) in such a flow is known (see, for example, Patent Literature 1).

Patent Literature 1: International Patent Publication No. WO2023/058625

However, in the case where management is performed only between the medical institution at which the specimen is taken and the medical institution at which the personalized vaccine is administered as described above, the identification of the patient himself/herself may not be sufficiently checked. That is, the management may be insufficient, so that there is a risk that the vaccine may be mistakenly administered.

An object of the present disclosure is to provide an information processing system, an information processing method, and a program capable of solving at least one of the problems described above.

An aspect of the present disclosure for achieving the above-described object is an information processing system including:

An aspect of the present disclosure for achieving the above-described object is an information processing method including:

An aspect of the present disclosure for achieving the above-described object is a program for causing a computer to perform:

An aspect of the present disclosure for achieving the above-described object is an information processing system including:

An aspect of the present disclosure for achieving the above-described object is an information processing method including:

An aspect of the present disclosure for achieving the above-described object is a program for causing a computer to perform:

For example, at a medical institution such as a hospital, a specimen such as blood or a part of a tumor of a cancer is taken from a patient, and based on the taken specimen, a so-called personalized vaccine or personalized therapeutic agent is prepared specifically for that patient through a plurality of institutions and companies. Then, the generated personalized vaccine or personalized therapeutic agent is administered to the same patient at a medical institution (which is the same as or different from the aforementioned medical institution).

As described above, in the process for generating and administering a personalized vaccine or a personalized therapeutic agent, a vaccine or a therapeutic agent generated based on a specimen taken from a patient needs to be administered to the same patient.

To enable this to be done, an information processing system according to this example embodiment is a system for ensuring that, for example, the process for generating and administering a personalized vaccine or a personalized therapeutic agent is correctly carried out by directly associating the patient himself/herself with the vaccine or therapeutic agent itself. Note that examples of personalized vaccines include a personalized cancer vaccine (PCV) and CAR-T.

That is, in the flow of administering a personalized vaccine or a personalized therapeutic agent, the information processing system according to this example embodiment checks the identification of a patient himself/herself more reliably through a biometric authentication and an electronic signature when a specimen is detected and when a vaccine or a therapeutic agent is administered. In this way, it is possible to, for example, greatly reduce the risk of mistakes being made in the administration of vaccines or therapeutic agents and mistakes in information of labels both of which would otherwise be caused due to insufficient checking (or confirmation) of the identification of the patient himself/herself.

shows a schematic hardware configuration of an information processing system according to the present disclosure. As shown in, the information processing systemaccording to this example embodiment has a hardware configuration of an ordinary computer including, for example, a processorsuch as a CPU (Central Processing Unit) or a GPU (Graphics Processing Unit), an internal memorysuch as a RAM (Random Access Memory) or a ROM (Read Only Memory), a storage devicesuch as an HDD (Hard Disk Drive) or an SSD (Solid State Drive), an input/output I/Ffor connecting peripheral devices such as a display device, and a communication I/Ffor communicating with external apparatuses.

is a block diagram showing a schematic system configuration of the information processing system according to the present disclosure. As shown in, the information processing systemaccording to this example embodiment includes a terminal, a management apparatus, and a biometric information database. Note that the terminal, the management apparatus, and the biometric information databasemay be connected to each other through, for example, a wireless LAN (Local Area Network) or Wifi (Registered Trademark).

The terminalis a specific example of the biometric information acquisition means. The terminalis composed of a portable terminal that a user can operate, such as a smartphone, a tablet computer, and a PC (Personal Computer). The terminalacquires biometric information of a patient. Examples of biometric information include the patient's face, iris(es), fingerprint(s), vein(s), voice print, palm print, and/or ear(s).

The terminalacquires biometric information of a patient based on, for example, an image of the patient acquired by a camera or a voice of the patient acquired by a microphone. The terminaltransmits the acquired biometric information of the patient to the management apparatus.

The management apparatusis an apparatus for managing the whole system and is configured as, for example, a server apparatus. The terminaland the management apparatusmay be formed as one integrated apparatus. Either the terminalor the management apparatusmay include the biometric information databasetherein.

The management apparatusincludes an authentication processing unitfor performing a process for authenticating a patient, a trace information generation unitfor generating trace information for tracing, i.e., keeping track of, a specimen of the patient, and a verification processing unitfor performing a process for verifying signature information.

The authentication processing unitis a specific example of the authentication processing means. The authentication processing unitperforms a process for authenticating a patient based on biometric information of the patient transmitted from the terminal. The authentication processing unitperforms the process for authenticating a patient by, for example, comparing biometric information of the patient transmitted from the terminalwith pre-registered biometric information.

The authentication processing unitmay perform a process for authenticating a patient by combining a plurality of pieces of biometric information of the patient with each other. For example, the authentication processing unitmay perform a process for authenticating a patient based on information on the face of the patient and information on his/her fingerprint(s).

The authentication processing unitstores the biometric information of the successfully authenticated patient in the biometric information databasein association with the identification information (ID information) of the patient.

The biometric information databaseis a specific example of the first storage means. The biometric information databaseis composed of, for example, the storage device.

The trace information generation unitis a specific example of the trace information generation means. The trace information generation unitgenerates signature information (electronic signature) of the patient based on the biometric information of the patient authenticated by the authentication processing unit. Further, the trace information generation unitgenerates signed trace information containing the generated signature information.

The trace information includes, for example, a QR code (Registered Trademarks), URL (Uniform Resource Locator) link information, or a barcode, and contains arbitrary information that is displayed in a form that can be read by a reader device. The management apparatusmay output the signed trace information as a label by a printer or the like.

For example, the label of the signed trace information, e.g., the label on which the signed trace information is printed, is attached to a vial, a container, or the like in which a vaccine or a therapeutic agent generated based on the specimen of the patient is contained. In this way, it is possible to directly associate the patient himself/herself with the vaccine or therapeutic agent itself.

Since the above-described signed trace information is verified by the information processing systemaccording to this example embodiment before the vaccine or therapeutic agent is administered to the patient, a doctor or a nurse can confirm that the vaccine or therapeutic agent was generated from the specimen of that patient.

Note that in the case where it is desired to also trace intermediate processes during the process through which the vaccine or therapeutic agent is generated from the specimen of the patient, the signed trace information may also be attached to the specimen or an intermediate product (including an electronic file) generated from the specimen.

The verification processing unitis a specific example of the verification processing means. The verification processing unitperforms a process for verifying the signature information of the signed trace information read by the reader deviceof the terminalbased on the biometric information of the patient authenticated by the authentication processing unit.

The reader deviceis a specific example of the trace information acquisition means. The reader deviceis composed of, for example, a barcode reader or a QR code reader. Note that the reader deviceis disposed inside the terminalin the above-described example, but the configuration of the reader deviceis not limited to this example. That is, the reader devicemay be formed separately from the terminal.

Next, an information processing method according to this example embodiment will be described with reference to.is a chart diagram of an information processing method according to the present disclosure.

Firstly, before starting a treatment, the terminalacquires biometric information of a patient and transmits the acquired biometric information of the patient to the management apparatus(S). The authentication processing unitof the management apparatusperforms a process for authenticating the biometric information of the patient. When the authentication has succeeded, the authentication processing unitof the management apparatusstores the biometric information of the patient in the biometric information database (biometric information DB)in association with identification information of the patient (S).

As shown in, for example, the management apparatusmakes, i.e., instructs, the terminaldisplay, on its screen, an authentication success window indicating that the authentication has succeeded and a patient consent window (consent information) for requesting the consent of the patient himself/herself as to, for example, taking a specimen from the patient (S).

When the patient performs a signature operation such as instructing to “Put signature” on the screen of the terminal(S), the management apparatusrequests the biometric information databaseto transmit biometric information corresponding to the identification information of that patient (S). Note that the management apparatusmay omit (or skip) the above-described process for requesting the consent of the patient himself/herself (S).

The biometric information databasetransmits the biometric information to the management apparatusin response to the above-described request. The trace information generation unitof the management apparatusgenerates signature information based on the biometric information (S). Note that in the case where the authentication processing unitperforms a process for authenticating a patient by combining a plurality of pieces of biometric information with each other as described above, signature information may be generated for each of the pieces of biometric information based thereon.

The management apparatusstores the signed consent information containing the generated signature information in the biometric information database(S). This signed consent information may be used later for auditing or the like.

Note that the consent information may contain, for example, in addition to the document of the consent of the patient himself/herself, a time stamp, a document in which the process for generating the vaccine is described, and identification information of the vaccine. The management apparatustransmits a signature generation result indicating that the signature has been generated to the terminal(S).

The trace information generation unitof the management apparatusgenerates signed trace information containing signature information, and transmits the generated signed trace information to a printer (S). The printer outputs the signed trace information as a label or the like. The label of the signed trace information, e.g., the label on which the signed trace information is printed, is attached to a vial, a container, or the like in which a vaccine or a therapeutic agent is contained.

Next, before the vaccine is administered to the patient, the terminalacquires the biometric information of the patient and transmits the acquired biometric information of the patient to the management apparatus. The authentication processing unitof the management apparatusperforms a process for authenticating the biometric information of the patient (S). When the authentication has succeeded, the authentication processing unitof the management apparatusstores the biometric information of the patient in the biometric information databasein association with the identification information of the patient (S).

The management apparatusrequests the terminalto display a verification request window (S). In response to this request, the terminaldisplays, as the verification request window, for example, a window for requesting to verify the signature as shown in.

In the verification request window of the terminal, the patient performs an operation such as instructing to “Verify signature”. The reader deviceof the terminalreads the signed trace information attached to the vial or the like of the vaccine or therapeutic agent, and transmits the read signed trace information to the management apparatus. Then, the terminalrequests the management apparatusto verify the signed trace information (S).

In response to this request, the management apparatusrequests the biometric information corresponding to the identification information of the patient from the biometric information database. In response to this request, the biometric information databasetransmits the biometric information corresponding to the identification information of the patient to the management apparatus. The verification processing unitof the management apparatusperforms a process for verifying the signature information of the signed trace information based on the transmitted biometric information (S).

When the verification of the signature information has succeeded, the verification processing unitof the management apparatusrequests the terminalto display, for example, a verification success window indicating that the verification of the signature information has succeeded and a pre-administration patient consent window (consent information) for requesting the consent of the patient himself/herself in regard to the administration of the vaccine as shown in(S). The terminaldisplays the verification success window and the pre-administration patient consent window in response to this request.

When the patient performs a signature operation such as instructing to “Put signature” on the screen of the terminal(S), the management apparatusrequests the biometric information databaseto transmit biometric information corresponding to the identification information of that patient (S). Note that the management apparatusmay omit (or skip) the above-described process for requesting the consent of the patient himself/herself (S).

In response to this request, the biometric information databasetransmits the biometric information corresponding to the identification information of the patient to the management apparatus. The trace information generation unitof the management apparatusgenerates signature information based on the biometric information (S).

The management apparatusstores the signed consent information containing the signature information in the biometric information database(S). The management apparatustransmits a signature generation result indicating that the signature has been generated to the terminal(S).

is a block diagram schematically showing a system configuration of an information processing system according to the present disclosure. The information processing systemaccording to this example embodiment further includes, in addition to the configuration of the above-described first example embodiment, a verification key databaseand a key parameter database.